FDA Approves Olumiant (baricitinib) Treatment for COVID-19 in Certain Hospitalized Adults
May 10, 2022 -- Today, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 11, 2022 Category: Drugs & Pharmacology Source Type: news

Enhertu Approved in the US for Patients with HER2-Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
Approval broadens indication for AstraZeneca and Daiichi Sankyo’s Enhertu to earlier use in metastatic breast cancer Based on ground-breaking DESTINY-Breast03 results showing Enhertu reduced the risk of disease progression or death by 72%... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 6, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
Voquezna Triple and Dual Paks each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB), and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in the overall... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 4, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cuvrior (trientine tetrahydrochloride) for the Treatment of Wilson ’s disease
Paris, France 2 May 2022– Orphalan SA (“Orphalan” or“the Company”), an international orphan drug development and commercialisation company, today announces approval of Cuvrior™, a new salt of trientine... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 2, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Camzyos (mavacamten) for the Treatment of Symptomatic NYHA Class II-III Obstructive Hypertrophic Cardiomyopathy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2022 Category: Drugs & Pharmacology Source Type: news

Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis
Across the two pivotal trials, Rinvoq delivered rapid and meaningful disease control with nearly half of ankylosing spondylitis (AS) patients achieving ASAS40 (51% and 44.5% with Rinvoq versus 26% and 18.2% with placebo) at week 14 compared... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2022 Category: Drugs & Pharmacology Source Type: news

Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
First novel, nonstimulant option for adults with ADHD in 20 years ADHD affects an estimated 10 million adults in the U.S. ROCKVILLE, Md., April 29, 2022 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vivjoa (oteseconazole) for the Treatment of Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection)
DURHAM, N.C.--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) approved Vivjoa (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2022 Category: Drugs & Pharmacology Source Type: news

Ultomiris Approved in the US for Adults with Generalised Myasthenia Gravis
First and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised myasthenia gravis Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Epsolay (benzoyl peroxide) Cream for the Treatment of Rosacea
NESS ZIONA, Israel and ZUG, Switzerland, April 25, 2022 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 25, 2022 Category: Drugs & Pharmacology Source Type: news

Veklury (remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19
Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 25, 2022-- Gilead... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 25, 2022 Category: Drugs & Pharmacology Source Type: news

Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for Caplyta (lumateperone) for Specific Patient Populations
Caplyta label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic impairment and patients who are concomitantly taking moderate or strong CYP3A4 inhibitors. NEW YORK, April 25, 2022 (GLOBE... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 25, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Alymsys (bevacizumab-maly), a Biosimilar to Avastin
BRIDGEWATER, N.J.--(BUSINESS WIRE) April 13, 2022 --Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the“Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 13, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Igalmi (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2022 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vijoice (alpelisib) for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)
Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2022 Category: Drugs & Pharmacology Source Type: news